The GLP Quality Assurance Unit performs inspections to ensure data integrity. Which phrase best describes this responsibility?

The GLP Quality Assurance Unit performs inspections to ensure data integrity. Which phrase best describes this responsibility?

• A. They monitor approved protocols and update SOPs
• B. They ensure protocol validation
• C. They review financial records
• D. They conduct inspections (audit) studies to ensure integrity of data

Answer: (D)

The main idea here is verifying data integrity through independent checks. The GLP Quality Assurance Unit exists to ensure that study data are accurate, complete, and traceable, and that the way studies are conducted complies with GLP. Describing their role as conducting inspections or audits of studies to verify data integrity best captures this independent verification process and how QA ensures the reliability of the data produced. Monitoring approved protocols and updating SOPs is about governance and ensuring procedures are current, but it doesn’t specifically describe independently checking the data itself. Protocol validation focuses on proving that a method works as intended, which is important but not the ongoing QA activity described. Reviewing financial records is outside the scope of GLP data integrity and QA for study data.

The main idea here is verifying data integrity through independent checks. The GLP Quality Assurance Unit exists to ensure that study data are accurate, complete, and traceable, and that the way studies are conducted complies with GLP. Describing their role as conducting inspections or audits of studies to verify data integrity best captures this independent verification process and how QA ensures the reliability of the data produced.

Monitoring approved protocols and updating SOPs is about governance and ensuring procedures are current, but it doesn’t specifically describe independently checking the data itself. Protocol validation focuses on proving that a method works as intended, which is important but not the ongoing QA activity described. Reviewing financial records is outside the scope of GLP data integrity and QA for study data.